VENTILATOR, CONTINUOUS, FACILITY USE
This device is manufactured by PHILIPS NORTH AMERICA, PHILIPS RESPIRONICS, RESPIRONICS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 2 | Patient |
| 2024 | Unspecified Respiratory Problem | 4 | Patient |
| 2024 | Unspecified Hepatic or Biliary Problem | 1 | Patient |
| 2024 | Unspecified Heart Problem | 2 | Patient |
| 2024 | Skin Inflammation/ Irritation | 2 | Patient |
| 2024 | Sinusitis | 1 | Patient |
| 2024 | Respiratory Arrest | 1 | Patient |
| 2024 | Pneumonia | 1 | Patient |
| 2024 | Nausea | 2 | Patient |
| 2024 | Low Oxygen Saturation | 1 | Patient |
| 2024 | Insufficient Information | 4 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Headache | 4 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dizziness | 3 | Patient |
| 2024 | Unexpected Shutdown | 1 | Device |
| 2024 | Temperature Problem | 1 | Device |
| 2024 | Protective Measures Problem | 2 | Device |
| 2024 | Pressure Problem | 1 | Device |
| 2024 | Power Problem | 7 | Device |
| 2024 | Peeled/Delaminated | 4 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | No Display/Image | 16 | Device |
| 2024 | Mechanical Problem | 24 | Device |
| 2024 | Mechanical Jam | 2 | Device |
| 2024 | Insufficient Flow or Under Infusion | 1 | Device |
| 2024 | Improper Flow or Infusion | 1 | Device |
| 2024 | Gas Output Problem | 2 | Device |
| 2024 | Failure to Run on Battery | 1 | Device |
| 2024 | Failure to Recalibrate | 45 | Device |
| 2024 | Failure to Power Up | 8 | Device |
| 2024 | Failure to Charge | 5 | Device |
| 2024 | Failure to Calibrate | 17 | Device |
| 2024 | Electrical /Electronic Property Problem | 30 | Device |
| 2024 | Display or Visual Feedback Problem | 16 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Device Damaged Prior to Use | 1 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2024 | Device Alarm System | 4 | Device |
| 2024 | Degraded | 11 | Device |
| 2024 | Defective Alarm | 1 | Device |
| 2024 | Crack | 4 | Device |
| 2024 | Circuit Failure | 27 | Device |
| 2024 | Charging Problem | 4 | Device |
| 2024 | Calibration Problem | 3 | Device |
| 2024 | Break | 3 | Device |
| 2024 | Battery Problem | 63 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Vomiting | 14 | Patient |
| 2023 | Unspecified Respiratory Problem | 83 | Patient |
| 2023 | Unspecified Kidney or Urinary Problem | 31 | Patient |
| 2023 | Unspecified Hepatic or Biliary Problem | 5 | Patient |
| 2023 | Unspecified Heart Problem | 7 | Patient |
| 2023 | Skin Inflammation/ Irritation | 16 | Patient |
| 2023 | Sinusitis | 3 | Patient |
| 2023 | Respiratory Tract Infection | 13 | Patient |
| 2023 | Respiratory Insufficiency | 3 | Patient |
| 2023 | Respiratory Failure | 2 | Patient |
| 2023 | Respiratory Arrest | 1 | Patient |
| 2023 | Renal Impairment | 1 | Patient |
| 2023 | Pulmonary Dysfunction | 4 | Patient |
| 2023 | Pneumothorax | 1 | Patient |
| 2023 | Pneumonia | 8 | Patient |
| 2023 | Pallor | 1 | Patient |
| 2023 | Nodule | 1 | Patient |
| 2023 | Nausea | 13 | Patient |
| 2023 | Nasal Obstruction | 1 | Patient |
| 2023 | Movement Disorder | 1 | Patient |
| 2023 | Lymphoma | 1 | Patient |
| 2023 | Low Oxygen Saturation | 2 | Patient |
| 2023 | Loss of consciousness | 1 | Patient |
| 2023 | Liver Damage/Dysfunction | 4 | Patient |
| 2023 | Ischemic Heart Disease | 1 | Patient |
| 2023 | Insufficient Information | 4 | Patient |
| 2023 | Inflammation | 17 | Patient |
| 2023 | Hypothermia | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 11 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 3 | Patient |
| 2023 | Headache | 55 | Patient |
| 2023 | Eye Irritation | 19 | Patient |
| 2023 | Dyspnea | 6 | Patient |
| 2023 | Dizziness | 53 | Patient |
| 2023 | Chronic Obstructive Pulmonary Disease (COPD) | 6 | Patient |
| 2023 | Cardiovascular Insufficiency | 4 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Cancer | 45 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Bronchitis | 2 | Patient |
| 2023 | Asthma | 38 | Patient |
| 2023 | Appropriate Term / Code Not Available | 5 | Patient |
| 2023 | Unexpected Shutdown | 4 | Device |
| 2023 | Tidal Volume Fluctuations | 2 | Device |
| 2023 | Thermal Decomposition of Device | 1 | Device |
| 2023 | Temperature Problem | 3 | Device |
| 2023 | Scratched Material | 1 | Device |
| 2023 | Pressure Problem | 4 | Device |
| 2023 | Power Problem | 2 | Device |
| 2023 | Peeled/Delaminated | 25 | Device |
| 2023 | Partial Blockage | 1 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Flow | 2 | Device |
| 2023 | No Display/Image | 19 | Device |
| 2023 | Mechanical Problem | 15 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Integrity Problem | 3 | Device |
| 2023 | Leak/Splash | 2 | Device |
| 2023 | Insufficient Information | 3 | Device |
| 2023 | Insufficient Flow or Under Infusion | 1 | Device |
| 2023 | Infusion or Flow Problem | 1 | Device |
| 2023 | Increase in Pressure | 1 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2023 | Gas/Air Leak | 1 | Device |
| 2023 | Gas Output Problem | 1 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Fitting Problem | 1 | Device |
| 2023 | Fire | 1 | Device |
| 2023 | Failure to Sense | 1 | Device |
| 2023 | Failure to Recalibrate | 38 | Device |
| 2023 | Failure to Power Up | 4 | Device |
| 2023 | Failure to Charge | 11 | Device |
| 2023 | Failure to Calibrate | 14 | Device |
| 2023 | Excessive Heating | 4 | Device |
| 2023 | Environmental Particulates | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 34 | Device |
| 2023 | Display or Visual Feedback Problem | 10 | Device |
| 2023 | Disconnection | 2 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Degraded | 168 | Device |
| 2023 | Defective Alarm | 1 | Device |
| 2023 | Decrease in Pressure | 7 | Device |
| 2023 | Crack | 5 | Device |
| 2023 | Contamination | 2 | Device |
| 2023 | Complete Blockage | 1 | Device |
| 2023 | Circuit Failure | 23 | Device |
| 2023 | Charging Problem | 1 | Device |
| 2023 | Calibration Problem | 1 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Battery Problem | 34 | Device |
| 2023 | Audible Prompt/Feedback Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2022 | Pneumonia | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Fever | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Tidal Volume Fluctuations | 3 | Device |
| 2022 | Temperature Problem | 2 | Device |
| 2022 | Pressure Problem | 3 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Peeled/Delaminated | 38 | Device |
| 2022 | Particulates | 1 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | No Pressure | 1 | Device |
| 2022 | No Flow | 1 | Device |
| 2022 | No Display/Image | 42 | Device |
| 2022 | Misassembly by Users | 1 | Device |
| 2022 | Mechanical Problem | 34 | Device |
| 2022 | Leak/Splash | 2 | Device |
| 2022 | Key or Button Unresponsive/not Working | 1 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2022 | High Readings | 1 | Device |
| 2022 | Gas/Air Leak | 1 | Device |
| 2022 | Failure to Recalibrate | 44 | Device |
| 2022 | Failure to Power Up | 11 | Device |
| 2022 | Failure to Charge | 67 | Device |
| 2022 | Failure to Calibrate | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 7 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Degraded | 86 | Device |
| 2022 | Decrease in Pressure | 7 | Device |
| 2022 | Contamination | 8 | Device |
| 2022 | Circuit Failure | 30 | Device |
| 2022 | Battery Problem | 67 | Device |
| 2022 | Application Program Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Unspecified Respiratory Problem | 2 | Patient |
| 2021 | Pulmonary Emphysema | 1 | Patient |
| 2021 | Dyspnea | 2 | Patient |
| 2021 | Confusion/ Disorientation | 1 | Patient |
| 2021 | No Display/Image | 1 | Device |
| 2021 | Microbial Contamination of Device | 1 | Device |
| 2021 | Failure to Charge | 1 | Device |
| 2021 | Device Emits Odor | 1 | Device |
| 2021 | Degraded | 47 | Device |
| 2021 | Contamination | 4 | Device |
| 2021 | Battery Problem | 1 | Device |